Jazz Pharmaceuticals PLC (JAZZ) 2013 Q1 法說會逐字稿

Welcome to the Jazz Pharmaceuticals first-quarter 2013 earnings conference call. Following an introduction from the Company, we will open the call to questions.

I will now turn the call over to Kathee Littrell, Vice President of Investor Relations at Jazz Pharmaceuticals.

Thank you very much, Cheverly. Thank you for joining us today on the Jazz Pharmaceuticals plc investor conference call. Today we reported our first-quarter 2013 financial results, and we've provided an updated 2013 financial guidance in our press release. The release is available in the news and events section of the Company's website.

With me for today's call are Bruce Cozadd, our Chairman and CEO; Kate Falberg, our CFO; Russ Cox, our Chief Commercial Officer; and Jeff Tobias, our Head of R&D and Chief Medical Officer.

Following some introductory remarks, we will open the call for your questions.

Please note that the statements we make on this call related to the future events constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include our comments related to the growth potential of the Company and certain of our products, corporate development initiatives, repurchases under and the effect of our share repurchase program, future financial results, future litigation, intellectual property and regulatory-related matters, future supply of Erwinaze, clinical trial enrollment and results, and other statements relating to our plans, expectations and intentions.

These forward-looking statements involve numerous risks and uncertainties that could cause our actual results to differ significantly from those projected, including risks and uncertainties associated with maintaining and increasing sales of Xyrem and our other products; the potential introduction of generic competition to Xyrem; potential unchanged or increased regulatory restrictions on Xyrem; developing and protecting our intellectual property; ongoing regulation and oversight by regulatory agencies; our dependence on key customers and sole-source suppliers, including our ability to resolve in a timely manner potential product supply shortages and meet product demand; pharmaceutical product development, clinical trials, and regulatory approval; and our ability to identify and acquire, in-license, or develop additional products or product candidates.

These and other risks related to our business are detailed in our SEC filings, including under the caption Risk Factors in our Annual Report on the Form 10-K for the year ended December 31, 2012, and our quarterly report on Form 10-Q for the quarter ended March 31, 2013, which will be filed this afternoon. We undertake no duty or obligation to update any forward-looking statements contained on this call as a result of new information, future events, or changes in our expectations.

On this call we discuss several non-GAAP financial measures, including adjusted net income, adjusted combined SG&A and R&D expenses, adjusted earnings per share, and adjusted effective tax rate. We believe that these non-GAAP financial measures are helpful in understanding our past financial performance and potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures. Reconciliations of GAAP to adjusted financial measures are included in our press release issued earlier today, which is available on our website.

I'll now turn the call over to Bruce.

Thank you, Kathee. Good afternoon, everyone, and thank you for joining us. 2013 is off to a strong start. In the first quarter, we saw record sales for Xyrem and Erwinaze. Our total revenues increased 91% to $196 million, compared to the first quarter of 2012. We realize adjusted net income of $84 million in the first quarter of 2013, reflecting the significant topline growth and attractive margins of our business. GAAP net income for the quarter was $43 million.

We are focused on unlocking the growth potential of our key products through solid execution in all of our business units, and by making selective investments in new initiatives. We'll also continue our focus on corporate development, with a goal of adding specialty products to our portfolio.

Today we announced that our Board has authorized a share repurchase program of up to $200 million. The timing and amount of repurchases will depend on a variety of factors, including stock price. We believe this presents an opportunity to increase shareholder value while maintaining significant financial flexibility to finance future corporate development opportunities.

I'll now comment on the three products in our portfolio that we believe have the highest growth potential -- Xyrem, Erwinaze and Prialt. Kate will then review our results for the first quarter and provide updates to our financial guidance.

Xyrem remains a key driver of our growth. In the first quarter of 2013, we were pleased to achieve 15% volume growth compared to the same period of 2012. The average number of active Xyrem patients grew to approximately 10,550 compared to 9500 in the same period of 2012.

Our efforts in reaching an expanded prescriber universe have contributed to the growth that we saw this quarter-end in 2012. We're making progress on growing prescriptions from the mid-decile physicians in our current call universe. And we continue to identify additional groups of physicians who are diagnosing and managing patients with narcolepsy. As part of our ongoing education efforts to raise awareness of the diagnosis and treatment of narcolepsy patients, we have developed Narcolepsy Link as a disease state resource. We have launched the Narcolepsy Link website where healthcare providers can participate in key-opinion-leader-led meetings and symposia, providing information related to the identification and diagnosis of narcolepsy, which we believe could lead to earlier patient diagnosis.

During the American Academy of Neurology meeting in March we presented the BOND -- that's Burden of Narcolepsy Disease -- study, describing healthcare utilization and costs associated with narcolepsy. This study evaluated the narcolepsy burden of illness in a US database of over 7 million patients with approximately 9300 diagnosed narcolepsy patients, compared to a control matched group. It demonstrated that narcolepsy is associated with substantial personal and economic burdens, such as significantly higher health care and drug utilization costs, and significantly increased short-term disability compared to the control group.

Next month, we will be presenting additional abstracts that build on our understanding of the burden of illness and the ability to diagnose and manage patients with narcolepsy at SLEEP 2013, the annual meeting of the Associated Professional Sleep Societies. As part of our lifecycle management for Xyrem, preclinical efforts are underway on JZP-386, formerly referred to as C-10323, the deuterium-modified sodium oxybate that we licensed from Concert in February. We plan to submit an IND later this year.

Now I'd like to provide a brief update on legal and regulatory matters related to Xyrem. As you know, we have numerous patents around Xyrem, including formulation, method of use to treat narcolepsy, and method of distribution. And we've been in IP litigation with Roxane Laboratories for some time. The court recently ordered a consolidation of the multiple proceedings and set a schedule for the case. Based on the court's scheduling order, we anticipate the trial could occur as early as mid-2014. But, of course, the actual schedule may ultimately vary substantially.

We are also in very early stages of ANDA litigation with Amneal Pharmaceuticals. As we have mentioned previously, we are engaged in ongoing communications with the FDA with respect to finalizing our deemed REMS documents. While we can't predict the final outcome of these interactions, we expect that the FDA will require REMS documents that will result in or permit modifications to aspects of our current deemed REMS, which may include the ability to distribute Xyrem through more than one pharmacy.

We also expect that the final REMS documents will include some new requirements. That said, we expect that we will continue to operate the Xyrem distribution system with the key features of the current system -- a single central pharmacy and a central database of prescription and patient information. We continue to believe that this is the safest and most appropriate approach to the distribution of this drug.

There are numerous intersections between these regulatory matters; our intellectual property; the potential for FDA approval of, and launch of, generic versions of Xyrem; and our ongoing ANDA litigation. We've discussed these complexities and related risks in detail in our SEC filings, including the 10-Q that we're filing today, so I won't attempt to discuss all the variables on this call.

We continue to believe in the strength of our overall intellectual property position around Xyrem, and in the value of our over 10 years of experience in using the Xyrem restricted distribution system to provide Xyrem to patients who need this important therapy, while maintaining patient and public safety. We will continue to seek to enforce and enhance our broad intellectual property position, and ensure the continued safe distribution of this drug.

Now let's turn to Erwinaze, which also had very strong performance this quarter. We are pleased with the growth of this product as we continue to add new accounts and see consistent reordering. We believe that our efforts to educate health-care providers on identifying hypersensitivity reactions to E. coli-derived asparaginase in acute lymphoblastic leukemia patients, and reinforcing the importance of continued asparaginase therapy, may be leading to greater utilization of Erwinaze.

We believe that continued growth for Erwinaze may come from ongoing efforts to educate health-care professionals about identifying hypersensitivity reactions; the evaluation and adoption of an asparaginase activity assay into ALL protocols; and increased utilization in the adolescent and young adult, or AYA, population.

In part due to the robust demand we are seeing in the US, uncertainty about our ability to use a recent product batch could result in a temporary out-of-stock situation later this year. This possibility is reflected in our updated guidance. We are working with our supplier to evaluate the potential steps that could be taken to avoid or minimize a disruption in the availability of Erwinaze. And we'll make every effort to meet patient demand.

We continue to pursue research and development initiatives to support our oncology franchise. Our ongoing trial evaluating the intravenous mode of administration for Erwinaze has nearly completed enrollment, and we anticipate results later this year. We believe that IV administration would be well-received by both patients and healthcare providers. We are working with hematologists and oncologists to plan and start a study in adolescent and young adult patients, and are also looking forward to presenting additional safety data from a compassionate use trial in patients over 16 years of age, in an abstract at ASCO 2013.

There is an important unmet medical need in the AYA population, where there is a dramatic decline in ALL survival beginning in adolescence. The data suggest that the use of asparaginase-based protocol in the AYA population improves patient outcomes.

Finally, as part of our lifecycle management, we are evaluating Asparec, a PEGylated recombinant Erwinaze-derived asparaginase in a Phase I PK trial in Europe. And we're currently in discussions with key pediatric ALL leaders in the US in preparation for initiating a second study evaluating Asparec.

Let me comment briefly on Prialt, our non-opioid intrathecally administered drug. We believe there are several growth opportunities for Prialt as the primary alternative therapy to morphine for patients with intrathecal pumps and severe chronic pain. We're excited to announce a collaboration with Medtronic, the market leader in IT pumps. Together, we will develop and implement joint speaker, physician education, and training programs. We've made progress on our long-term growth strategy for Prialt, including continuing our launch of the NAVIGATOR program that has enrolled over 65% of our accounts to date.

As a reminder, perceived reimbursement difficulties were identified in our market research as the top reason that physicians do not use Prialt more broadly. Our NAVIGATOR system provides physicians and patients with increased reimbursement options and reimbursement assistance.

Another core area of focus for Prialt has been planning for the launch of our Prialt registry, known as PRISM, Patient Registry of Intrathecal Ziconotide Management. The first patient is anticipated to be enrolled mid-year. This registry will evaluate the effectiveness of Prialt therapy for the management of severe, chronic pain through the reporting of patient outcomes. PRISM will provide data that may help physicians optimize the management of patients on Prialt. Taken together, we believe that these approaches will support our long-term growth strategy for Prialt.

On the corporate development front, we continue to work to acquire or in-license additional marketed specialty products, or products that are close to regulatory approval. We believe that our strong balance sheet, efficient corporate structure, demonstrated expertise in specialty markets, and track record in successful executions of business development transactions, position us well.

I'm also pleased to note that Matt Young has joined us as Senior Vice President of Corporate Development, reporting to Kate. Matt has extensive experience as a healthcare investment banker, including involvement in many, many corporate development licensing and financing transactions.

Kate, with that, let me now turn the call over to you.

Thanks, Bruce, and good afternoon, everyone. Beginning with the top line, total revenues for the quarter were $196 million compared to $103 million in the same period last year. This increase was primarily driven by inclusion of revenues from the acquired EUSA Pharma business, and increased sales of Xyrem. Due to strong first-quarter performance, we have increased our revenue guidance for 2013. We expect robust topline growth, with total revenues in the range of $830 million to $860 million, up 42% to 47% on an absolute basis; and 25% to 30% on a pro forma basis.

Net sales of Xyrem for the quarter were $118 million, compared to $73 million in the first quarter of 2012. We were pleased with the year-over-year volume growth of 15% in the quarter, which reflects not only the increase in the active patient pool, but also a continued improvement in our ability to manage the normal first-quarter issues relating to insurance changes and deductibles through our suite of reimbursement-related services.

We saw higher utilization of our coupon program in the quarter, which was reflected in an increase in gross to net deductions. Due to the strength of the business in the first quarter and the continued solid reimbursement environment, our net sales guidance for Xyrem this year is now increased to a range of $540 million to $555 million.

Turn to Erwinaze, first-quarter worldwide net sales were $42 million, up 27% from pro forma net sales of $33 million in the first quarter a year ago. This year, we expect strong growth for Erwinaze, with net sales now projected to be $150 million to $175 million worldwide. This guidance includes the downside uncertainty for Erwinaze due to the recent batch issue, as Bruce mentioned, and includes the upside related to the recent strong demand that we have observed.

US sales now represent more than three-quarters of worldwide sales.

Net sales of Prialt were $5 million in the quarter; and on a pro forma basis, net sales were $10 million for the same period in 2012. As a reminder, net sales for the first quarter of 2012 included $5 million related to a shipment to Eisai for distribution in Europe. We anticipate that we will be providing product to Eisai again by the middle of this year, so there will be some variability in our quarterly numbers for Prialt.

We're focused on the growth drivers that Bruce outlined, and continue to believe that Prialt can be an important part of chronic intrathecal pain management.

Net sales of our psychiatry products were $18 million in the first quarter, down slightly from the pro forma net sales for the same period a year ago. First-quarter net sales of the psychiatry products were impacted by the launch of a generic version of Luvox CR in March. Combined SG&A and R&D expenses for the quarter totaled $81 million compared to $48 million for the same period last year. Adjusted combined SG&A and R&D expenses for the quarter were $62 million, or 32% of revenues; compared to $39 million, or 38% of revenues, in last year's first quarter.

This year, we continue to expect our adjusted combined SG&A and R&D expenses to be in the range of $260 million to $275 million, essentially unchanged as a percent of revenues from the first quarter.

Turning to taxes, our adjusted effective tax rate for the first quarter was 18%. We continue to expect our 2013 adjusted effective tax rate to be in the high teens. The GAAP effective tax rate, which is impacted by various non-cash items, is expected to be in the high 20s. We reported adjusted net income of $84 million, or $1.37 per share for the quarter; compared to $52 million, or $0.89 per share, for the first quarter a year ago.

In 2013, we expect substantial growth in the bottom line, as reflected in our increased guidance of $379 million to $392 million of adjusted net income, or $6.10 to $6.30 of adjusted EPS. Our balance sheet remains strong, as we ended March with $451 million in cash and investments, and a balance of $451 million of debt. Our new share repurchase program is expected to be accretive for shareholders, while not limiting our ability to pursue attractive business development transactions.

In closing, we are very pleased with the strong start to 2013 and the momentum in our business. Thank you for joining us on the call today.

I will now ask the operator to open the line for your questions.

(Operator Instructions). Louise Chen, Guggenheim.

Hi, good afternoon. Thanks for taking my questions. I had a few. First question I had is, I haven't had a chance to look at your filings yet, but just curious if you could give a little bit more color regarding the REMS update that you're working on.

And then, secondly, on Erwinaze, maybe if you could tell us what quarter we should expect the stock-out to be, and what the impact might be that quarter relative to the other quarters. And then on JZP-386, if you could give us some background as to what might it take to get this product commercialized and to market. Thank you.

Okay, Louise. Those questions spanned the gamut. Let me start with -- I'll take them in order. On the REMS question, in light of where we are in our ongoing litigation and in our ongoing dialogue with FDA, and the sensitivity of those discussions, which we would like to conclude as quickly as we can, we really aren't going to be able to provide more detail than is provided in our SEC filings, which should be available momentarily.

As you can imagine, our primary objective is to maximize the chance of successful outcomes in both the regulatory conversations and the litigation. And we believe that minimizing the risk of being in a position where our public statements could compromise those outcomes would be a bad place for all of us to be in. So we're being a little circumspect right now in what we say. And we hope investors will understand why we're doing that.

On Erwinaze, we're giving you real-time update, that, due to high demand and production capacity constraints, any perturbation to our supply chain right now has the potential to cause a stock-out. You probably noticed that if you look at the net sales range we give for Erwinaze, it's a little broader than we would give normally. And that's designed to encompass the range of potential outcomes right now.

And our primary focus here is on patients, making sure patients get the necessary therapy. And we and our supplier will do everything we can to avoid or minimize a stock-out. It's still many months away. I can't really tell you specific timing, other than later this year, because it really depends on both the supply and demand side of that equation and how we manage it between now and then.

I'll remind you that, as a practice, we intentionally give annual guidance, not quarterly guidance. So I apologize if it's going to make modeling out quarterly progressions a little tougher. But we're trying to make sure people understand where we are going to be for the year as a whole.

On JZP-386, we're dealing with a preclinical compound. And part of moving into human clinical trials is a dialogue with FDA. But even post- that dialogue, I think the ultimate determination of what exactly it will take to move all the way through regulatory approval and onto the market is going to require all of us -- us and the regulatory body -- in seeing some data, so there's probably not a lot more we can say at this point on that.

Okay, thank you.

Gregg Gilbert, Bank of America.

Thank you. I was hoping you could comment a little bit more about that very high volume growth you saw, the acceleration from the recent quarter's level on Xyrem. And then on the buyback, is the message that you plan to use it soon, or that the authorization is there if you need it?

Thanks, Gregg. Let me have Russ take the Xyrem volume growth question, and maybe Kate can comment on the repurchase.

Yes, Greg, we've had a combination of things happen on Xyrem, so it's driven primarily by the fact that we've held onto patients. And going from Q4 to Q1, we've done a much better job of managing that transition. So, taking those patients into Q1, obviously we benefit from that. In addition to that, we've had good progress in trying to get mid-decile physicians to be more productive prescribers from us. So it's a combination, really, of the hard work of the field being more productive, and the programs that we have in place that are now starting to pay off.

And, Gregg, on the buyback program -- so, the Board has authorized up to $200 million to be used in management's discretion. So we will use our discretion through the balance of the year. We'd like to retire the stock, because the earlier you get it retired the more accretive it is. But we'll be mindful, of course, of the stock price and market factors and other potential uses for the cash as well.

And, Bruce, could you tell us if this REMS discussion is something that Jazz asked for, or is just reacting to? Can you at least talk about that before the details come out?

Yes, sure, Gregg. This is an ongoing part of a process that's been going on for many years, actually, which is -- the ultimate conversion of risk MAPs that existed before FDAAA into the more final REMS format. We're not the only product going through that process. It's taken a long time. There isn't a particular PDUFA clock on this. But this is an ongoing discussion that's been happening for a long period of time.

Thanks.

Ami Fadia, UBS.

Yes, good evening. Could you give us your latest thinking around the expected volume growth for Xyrem for the year? And with respect to the REMS discussion, I probably didn't catch everything that you said in your prepared remarks, but is the change in REMS going to allow two pharmacies to be distributors for the drug? Could you come back and clarify that? Thank you.

Yes, so let me have Russ address the first part of your question, which is expected volume growth for Xyrem for the full year.

Yes, so we've historically said that we believe we'd see high-single-digits to low-double-digits. So I think that it's feeling more and more like low-double-digits.

And then, Ami, on the second part of your question, what we've said is we expect that the FDA will require some -- or permit some modifications. We don't actually know where that's going to end up. So I can't get more specific other than to say, among other things, it could result in ability to use one or more pharmacies.

Okay. But still use a centralized database?

Again, we don't know -- we won't know until those discussions are concluded, what will change and what won't change. And at this point, we're trying to avoid speculating. But our goal is to get that finalized, and then we'll all see the outcome.

Just last question on this, when do you expect the final outcome?

We really can't predict. I think we and FDA both have a desire to get to the end here. But we both want to get to the right end, and it's outside of my control to predict time.

Thank you.

Bill Tanner, Lazard Capital Markets.

Thanks for taking the questions. I had one just quickly on the guidance. Bruce, I think you mentioned on the last call that the Xyrem guidance for 2013 did not contemplate a price increase. And I'm curious if there is one contemplated now in the guidance. I have a couple of follow-ups, if I could, please.

Yes, Bill, you're probably going to get the same answer from us you usually get to this question -- which is, we generally don't speculate on prospective price increases. Specifically, I think our guidance range that we've given for this year is our best estimate based on everything we know today. And you're probably not going to get more out of us than that.

Okay, that's fine. Fair enough. I just wanted to see if there was any departure from what you said before. And then on the REMS, Bruce, so you did mention that the changes could include the distribution of Xyrem through multiple pharmacies, so you didn't say sodium oxybate. So, I don't know if there is a distinction there, and whether there would be a need for Jazz, your company, to have a second pharmacy for whatever reason. So I don't know if you could maybe comment on that.

Well, I specifically said Xyrem, Bill, because it is the only approved product out there. And we are dealing with our REMS for our product, so I can't speculate beyond that. I know it sounds like a subtle distinction, but I talked about what was possible in what the FDA could require. I also said that our current intention is to continue to distribute the product as we do, because we've got a system that we believe is working well.

But, operationally for Jazz, would it make sense to have another pharmacy? I don't know if you can comment on that.

Based on everything I know today, no. But we've got a system that we think is working well.

Right. And then one question for Russ -- and I think you may have already addressed it somewhat. So you've got a 15% year-over-year volume growth on about an 11% year-over-year patient growth. So would you attribute it to better compliance, persistence, the delta there?

Yes, Bill, just before Russ gets into more detail, I'll just remind you that the number of patients on average over a three-month period versus exactly how many shipments those patients that are in that number get, has some sort of random distribution by when their shipments occur. And some of them can happen right before a quarter-end, or right after a quarter-end. And so you're always going to get a little disconnect between those two numbers, that -- whatever Russ says next, I don't want people to read too much into. There's just some variability there.

Yes, there clearly isn't a distinct relationship, and there is variability with that. And, Bill, you know these numbers -- if you go back to Q4 of 2011, we had growth of 8.6%. And then, in the first quarter of 2012, we went 9.9%; and then 11.5%; and 8.7%; and 13%; and now 15%. You can see that, over the last two quarters, it looks like the trajectory is going in the right direction in terms of future growth.

I think that we've always characterized our growth as a combination of things. It's persistence and compliance, as well as a new target group of physicians that we're calling on and the existing universe becoming more productive, and I wouldn't change that position.

Okay, thank you.

David Amsellem, Piper Jaffray.

Thanks. I just had a few. So let's come back to the REMS. I'll start there. If the FDA is amenable to allowing distribution of Xyrem by other pharmacies, does that change in any way your openness to possibly settling your patent litigation with Roxane or even Amneal? How should we think about that?

So, complex question, David, and probably not one I'm go on record on in any specific way other than to say, in general, our approach here is to do what we think creates the most value for our shareholders; and also ensures continued availability of and safe distribution of this product that's so important to us. And those goals haven't changed. As the situation changes, for any reason -- regulatory interactions, litigation-related, or otherwise -- we will, of course, factor that into our thinking. But there's nothing magic about this moment that changes the fact that that's been our general approach.

Okay, and then another Xyrem question. This is more of a commercial question. Can you talk about the current extent of prior authorizations on the product, and how has that changed from a year ago, and how that may or may not impact your thinking on additional aggressive pricing action?

Yes, sure, David. If you go back two years ago, we were about one-third of patients for getting prior authorizations. And we've moved up, over a period of that two years, to get to about 50%. And we're still right around 50%, so I don't see anything dramatically changing in terms of overall prior authorization. We're seeing more patients getting re-authorizations than we saw before. But, again, that doesn't really change the landscape, and doesn't make me think differently about our ongoing ability to look at pricing elasticity.

Okay, and then one last one, if I may, on JZP-386. I know it's early, but is it reasonable to expect, after the IND PK study in healthy adults? And then could we possibly see that PK data sometime next year? Is that kind of a reasonable way of thinking about the next steps?

This is Jeff. It is relatively straightforward, standard development path, in that we are in the preclinical phase. We're trying to understand the molecule and what it does. And in the next case, it would be to look in humans; and most likely, without saying for sure, that it would be a PK study in normal volunteers. When that would happen really relates to the sequence of events that are leading up to our ability to do that trial. That is what we need to get our IND completed.

And are also looking at a number of other factors that relate to when and where you can do trials with Schedule I material, which may impact the timeline on that. So, more later, as far as the specifics on the timeline.

Okay, thank you.

Ken Cacciatore, Cowen and Company.

Hi, thanks. Bruce, I was just wondering, and I know this is a bit speculative, but shouldn't we assume that by locking in a REMS or agreeing to a REMS that has multiple distribution sites or more than one pharmacy, that this is the last step from a regulatory process to approving that generic?

And then maybe help us -- because we're going to have to prepare your shareholders for the ramifications of an approval -- can you just talk about, litigation-wise, preliminary injunctions and some of the legal steps you can take to prevent launch, to be able to hold them off to get to your litigation? Thank you -- make sure your patents are defended.

Yes, Ken, a couple comments. The discussion we're having with FDA right now is around converting our deemed REMS to a final REMS for our product. And I don't think it's as easy as drawing the conclusions you're drawing.

In terms of legal steps we could take, I really won't speculate on that. We have complex litigation going that we think, given that it involves multiple patents, would cause anyone who did get -- if they got an approval -- to think twice about launching at risk. But that's somebody else's decision.

I guess I would just ask, so finalizing your REMS you think does not have any implications to the eventual generic approval? Again, just in the spirit of trying to make sure everyone is on the same page with what to think about in the next 6 to 8 months.

Yes, again, that's calling for speculation about what's going on at FDA that we don't have visibility into. I'll remind you that we have passed our 30-month stay last month. So at this point, it is possible FDA could approve another product, but whether or when that will happen is beyond my ability to predict.

If we're past the 30-month stay, is there any worry that Roxane's exclusivity is going to be forfeited, and maybe implications to what that means in terms of settlement? Or should we not be speculating that their exclusivity would be forfeited?

All I can say is there are two ANDA filers, and the second is pretty far behind the first, just in terms of when they commenced their filings and where we are in litigation. So I would suspect that's not a near-term concern.

Okay, thank you.

Irina Rivkind, Cantor Fitzgerald.

Hi, thanks for taking the question. Maybe if I could rephrase the REMS question a different way. In general, from a regulatory perspective, can the FDA approve a generic for a compound that does not have a finalized REMS, and has it done so in the past? That's the first question.

And then the second question is on Erwinaze. And you mentioned that it was a batch that you're seeing that might be a problem. And I was wondering if you could characterize the size of the batch. Is it something that's a month's worth of supply or something like that? Thanks very much.

On the first question, that's a complex question. And I'm not sure I want to spend time walking through that on this call. I'd say some of the answer to that, or at least FDA's position as to a piece of that, can be found in the response to the second citizen petition from December. And we'll spell some of that out in the 10-Q, which hopefully all of you will have imminently. It was also spelled out, now that I think about it, in our 10-K, so that should be helpful.

On Erwinaze, I'd rather not get into a specific conversation of the size of batch. Because if I do that, I think you're going to draw conclusions you shouldn't be drawing right now about what that would mean for supply. Again, we're working with our supplier to think very carefully about how we manage demand and supply over the balance of the year to get to the best outcome for patients. And giving you a specific batch size for that batch isn't going to help you get to the answer.

And maybe if I could just do one more follow-up. On the Erwinaze market in general, could you just comment on the market dynamics? We know that Elspar has left the market. And can you just talk about what is evolving in terms of what's the new first-line agent and second-line agent and so forth? Thanks.

Yes, so the first-line agent is Oncaspar. I would characterize that there is not a first-line and second-line. But if somebody, in fact, has an allergic reaction to Oncaspar, typically they then they'd go with Erwinaze. And that is a dynamic we're seeing in the marketplace today.

Thank you.

Douglas Tsao, Barclays.

Hi, good afternoon. Thanks for taking the questions. And not to belabor the point, but obviously the negotiations, Bruce, over the REMS program have been ongoing for some time. Just trying to understand the timing in terms of disclosure today, what precipitated your noting the possibility in terms of opening it up to additional distribution? And was this a change that you sought? Because, obviously, the REMS system has proven quite successful in terms of the safe distribution of the product.

Yes, so Doug, on the first part of the question -- why now? I think any time we come up to a regular disclosure point, we try to factor in everything we know and give a good overall description of where we are. And given where we are now, as opposed to the last time we did significant disclosure, this appeared to be the right disclosure to make. I know it may not sound like it from my answers, but we're actually trying to be pretty transparent here, given that we don't actually know where this is going to end up.

I will also point out that we just announced the potential for a share repurchase program. And we want to be in the position where we've made full disclosure, so that we're not hanging onto information that's non-public that could keep us from being able to move forward with other plans we have.

And then, I think I'll decline to comment on the -- was this a change we sought, other than to reiterate my comment that we don't necessarily anticipate that we will change the way we distribute the product. We think it's working well the way it's working now.

Okay. And then, maybe this is a question more for Russ, but in terms of the new patient additions that you highlighted -- I think it was on 4Q call -- in terms of helping to contribute to volumes, I know -- I think it was in the middle of 2011 you had started to roll out or detailing some new prescribers and new doctors who were treating narcolepsy patients but weren't prescribing Xyrem. I was just curious where you were in that process, because I believe you were doing it in stages. Have you gone out and touched all those doctors that you had identified? Or is that still something that's going to play out over the next 12 to 18 months?

Yes, so we've approached this in specific waves of being able to generate potentially new data. The first group that we described was a group that we went out and purchased claims data, triangulated that against people who were prescribing for narcolepsy as well as using stimulants, and then took that against our existing call universe. And we found there was approximately 1000 physicians out there that weren't on our current call universe.

We've translated about 250 of those into meaningful prescribers now. So that's done; that's behind us. We've done a refresh since then, and there's about another 100 or so that we went after in the fourth quarter of last year. And we are now in the process of actually looking at another way of identifying what we believe are narcolepsy treaters and going after those. And we've identified about another 900 physicians.

So when it's all said and done, we started with a universe that was 70% of our business coming from about 750 physicians. We're now at a universe of probably approaching 4000, of which there is much more diversity in terms of where that business is coming from.

And, Russ, as a follow-up, of that -- how much additional -- when you're talking about the next wave of doctors you've identified, is that 4000 going to 5000? 4000 going to 4400? Or some perspective would be helpful.

Yes, I think that you're tapped out somewhere between 4000 and 500. As you can imagine, we are still prospecting that new group. So to give you the final number would be premature, but we're somewhere between 4000 and 4500.

Okay, great. Thank you.

Jonathan Eckard, Citi.

Hi. Thanks for taking my question. So, real quickly on Erwinaze, this is an asset that is continuing to grow and help diversify the top line. Are there potentials to look into secondary sources to help prevent, maybe, disruptions going forward, when it could be a pretty important and strategic asset to the top line?

And then I have a quick follow-up on REMS -- no, just teasing -- a quick follow-up on the deuterium sodium oxybate, afterwards.

Okay. So, I'll take the first one, and we'll come back to you for your follow-up. I would say in general we remain focused -- it's not a new focus of ours -- on ensuring that we have the most robust supply chain for all of our key products, not just Erwinaze. And, where possible, to bring on extra capacity, redundant capacity, second-source capacity; that is often difficult to do in our industry, and not something that can be done quickly. So I don't want to hold out any hope that that's a turnkey and we've got a new solution.

But we clearly are interested in making sure that we have reliable supply for our current level of demand, but that we also continue to bring on additional supply -- so that, to the extent we're successful at helping more patients, that we can in fact broaden the use of the product. So, everything is on the table, although that's not just in response to this situation, but a great question.

And why don't we come back to you for the JZP-386 question.

So, you answered most of them. I guess you noted that potentially locations of doing the trial based on being a Schedule III/Schedule I agent. Are there any additional hurdles -- preclinical hurdles, pre-IND -- that need to be done with an agent like this? And with regards of trying to get this into the clinic, if you were to rate it as a priority of 1 to 10, how much of a priority is this to really move this agent forward, in your mind?

Well, I think the answer is, is there anything special about these that we need to do in order to move it into the clinic? And one of the nice parts of dealing with a compound like this is that there's a great deal known about the parent compound. But by altering it with the deuterium atoms, you do have changes to the molecule that you need to characterize, and that's what we need to do prior to going into the clinic. Some of this is done, and some of it still needs still to be done to move forward.

But, again, it's really the -- I'd say there was nothing special; but, in fact, we may be able to rely on some of the data we've already generated with the Xyrem to help support the development of the molecule.

And then on the priority question, I would say that the reason we entered into this transaction in February is we're very excited about it. And we have a lot left to learn, but I think we and Concert together are very interested in moving this forward.

Thanks very much.

John Newman, JMP Securities.

Hi, guys. Thanks for taking the question. I apologize if this has already been asked, but on Erwinaze have you been able to manufacture additional batches successfully? And going forward, over the long-term, will you be able to increase the capacity at this current supplier that you're working with? Thanks.

John, on the first question, we have other production in process, not yet all the way to the market. So I can't answer that question other than to reiterate what I said, which is we absolutely believe this is a temporary batch-specific issue as opposed to a source of continued uncertainty. If that's where you were going with that, which is a great question, by the way.

And in terms of ability to increase capacity -- again, we're focused on that. But it's not an easy or quick thing to do. So, yes, we're working on it, but I don't want to promise quick results. But we and our supplier are working together, and I think have made some improvements already, and we'll continue to work together to make additional improvements.

Great. And if I could ask one additional question on the REMS program. Do you anticipate being able to disclose to the Street when you feel that the negotiations are finished?

Yes, good question, John, and a tricky one. In my experience, the negotiations are finished when you're done and you've got a signed-off document. And I say that with all respect to the FDA. They've got a tough job, and I think they always reserve the right to consider new information, right up until the second something is done. When would be in a position to make additional disclosure, we'll reevaluate that on an ongoing basis; certainly quarterly. And if we feel that we are in a meaningfully different position, and that information should be made public, we'll do so.

But the basic answer is, you're done when you're done. And until then, there's always some uncertainty. And that's why we're trying to avoid getting pinned down more, because we respect that that uncertainty exists.

Great. Thank you very much for answering the questions.

And, Operator, last question.

Difei Yang, WallachBeth Capital.

Hi. Can you hear me okay?

We sure can.

Great, great. Just a couple questions. On Erwinaze, to begin with, could you help me to understand a little better with regards to -- we see this tremendous revenue growth. Could you give us a little bit more color on the volume growth versus the price growth?

Yes, so, we have only 3% in terms of additional pricing action that we've seen in 2013. So this is really a reflection of volume growth. So, volume growth is really coming from the fact that, if you think through what was happening at this time last year, it was a recently launched product through EUSA. And EUSA was not fully resourced. In the third quarter of 2013 -- or 2012, we actually did put the right resources in place to maximize the opportunity for the launch.

And I think what you're seeing now in the fourth quarter, and also the first quarter of 2013, is the reflection of a fully resourced group looking at maximizing reimbursement, maximizing new accounts, and bringing additional business online. So I think that's really what's driving it, is just volume from having a fully resourced salesforce.

Yes, thank you. Another question with regards to the collaboration agreement signed between you and Medtronic. Could you comment on the economics?

Yes, so no economics involved here. This is a sharing of costs related to meetings and speakers programs. We obviously are looking at how we can maximize potential with their existing salesforce as well, so there is really no economics involved. It's really just a reflection of what we can share in terms of meetings and programs at this time.

Yes, thank you.

Okay, Operator, I'm going to take the call now. In closing, I want to first thank you all for joining us today; and a reminder that Jazz will be attending and presenting at a number of upcoming conferences and meetings over the next month or two -- the UBS Healthcare Conference later this month; and then, the Jeffries Healthcare Conference in June; and, finally, a Lazard investor conference call from the [suite] meeting in Baltimore. So we hope to see many of you at one of these conferences. And if you're unable to attend, we will post webcast links on our website.

So, again, thank you for joining us today. And this will end the call.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. You may now all disconnect, and have a great day.